Resources

United States (U.S.): Food and Drug Administration (FDA)

• Current Good Manufacturing Practice Regulations
  • Finished Pharmaceuticals (human and animal products): 21 CFR 210 and 21 CFR 211
  • Biological products: 21 CFR 600
  • Blood and blood-derived products: 21 CFR 606
  • Medical devices (“Quality System Regulation”): 21 CFR 820
  • Food for human consumption: 21 CFR 110
  • Dietary supplements (published by FDA in June 2007): 21 CFR 111
• Pharmaceutical CGMPs for the 21st Century: Guidance Document (2004)
• Quality System Approach to Pharmaceutical CGMP Regulations: Guidance Document (2006)

• GMP requirements for Active Pharmaceutical Ingredients (APIs) –– also known as ICH Q7.

• Interested in the first CGMP regulations that came out in 1963? Here’s a pdf of the original FDA regulations.
• Before the 1978 CGMPs were issued (the version that is still being used in the U.S.), a draft version was released and comments from the industry were requested. These comments and FDA’s responses were published in the “Preamble” to the CGMPs.

Australia: Therapeutic Goods Administration (TGA)

• Australian Code of Good Manufacturing Practice for Medicinal Products

Canada: Health Canada

• Good Manufacturing Practice (GMP) and guidance documents

Europe: European Medicines

• Volume 4 - Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice and related Annexes and Glossary

   

~For FDA's GMP Guidance Documents, click here ~